Open-Label Extension of LOCKCYST Trial (LOCKCYST-ext)

Radboud University Medical Center

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Autosomal Dominant

Polycystic Kidney

Polycystic Liver Disease

Hepatomegaly

Liver Diseases

Treatments

Drug: lanreotide

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00771888

NL16194.091.07

Details and patient eligibility

About

Positive data originating from two polycystic liver patients treated with somatostatin analogues, showed a volume reduction of 38.3% and 14.9%. These two patients had complicated polycystic livers and no other therapeutic options were available.

Patients who participated in LOCKCYST trial are able to benefit from active treatment. Participants will be actively treated for 24 weeks.

Full description

van Keimpema L, de Man RA, Drenth JP. Somatostatin analogues reduce liver volume in polycystic liver disease. Gut 2008 September;57(9):1338-9.

Enrollment

54 estimated patients

Sex

All

Ages

18 to 88 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participated in the LOCKCYST trial
18 yrs-of age
Multiple cysts > 20
Cooperating patient
Is willing and able to comply with the study drug regimen and all other study requirements.
Willingness to give written informed consent

Exclusion criteria

Use of oral anticonceptives or estrogen suppletion
Females who are pregnant or breast-feeding
History or other evidence of chronic pulmonary disease associated with functional limitation
History of severe cardiac disease (eg, NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases). In addition, patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled.
History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
Symptomatic gallstones (lanreotide decreases gall bladder volume)
Renal failure requiring hemodialysis